MODIFICATION TO D-TRONPLUS
FDA 510(k) clearance K043000 · decided 2004-12-01
Clearance details
- K-number
- K043000
- Device name
- MODIFICATION TO D-TRONPLUS
- Applicant
- Disetronic Medical Systems AG
- Decision
- Substantially Equivalent
- Date received
- 2004-11-01
- Decision date
- 2004-12-01
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. recall (Z-1413-06) | Disetronic Medical Systems, Inc. | 2006-09-12 |
| Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243 recall (Z-1105-05) | Roche Diagnostics Corp. | 2005-08-06 |